Parental Comprehension of Standard and Simplified Information Consent Forms in a Pediatric Clinical Trial Simulation – A Randomized Controlled Study
DOI:
https://doi.org/10.7202/1124207arKeywords:
information consent forms, simplified, comprehension, validated questionnaireLanguage(s):
EnglishAbstract
Background: Informed consent forms (ICFs) are a mandatory prerequisite for participating in clinical trials. In pediatric studies, the ICF is generally signed by the child’s parents. The ICFs designed for clinical trials are often lengthy and complex to understand. We conducted this study to determine if a simplified ICF would improve parental understanding compared to a standard ICF. Methods: A single-centre, single-blind, randomized controlled trial featuring two fictitious ICFs took place in a tertiary Canadian mother and child university hospital. Parents of hospitalized children were assigned to read either a standard or simplified ICF. Parental comprehension was measured using the Modular Informed Consent Comprehension Assessment (MICCA) questionnaire. The primary outcome of this study was to assess the proportion of parents with a MICCA score of 75% or above. Results: One hundred and fifty participants answered the study questionnaires. The primary endpoint was reached by 55.7% of the participants who read the simplified ICF compared to 46.2% in the standard ICF group (p=0.303). The mean MICCA scores were 17.87 and 17.75 points, respectively (p=0.847). Themes that were poorly understood by both groups were the study procedures, the adverse effects, the other available treatment options as well as the main benefits and purpose of the study. Conclusion: This single centre, single-blind, randomized controlled study showed that the comprehension was similar between a simplified and a standard ICF. This suggests that using simplified ICFs does not improve nor impair parental comprehension. Therefore, a simplified ICF should be used as frequently as possible in pediatric research projects.
References
1. Roth-Cline M, Nelson RM. Parental permission and child assent in research on children. Yale J Biol Med. 2013;86(3):291-301.
2. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-4.
3. Code Civil du Québec. CCQ 1991.
4. Government of Canada. Comité d’éthique de la recherche: Processus de consentement. Ottawa; Health Canada-PHAC Research Ethics Board Secretariat; 2023.
5. Leibson T, Koren G. Informed consent in pediatric research. Pediatric Drugs. 2015;17(1):5-11.
6. Hazen RA, Drotar D, Kodish E. The role of the consent document in informed consent for pediatric leukemia trials. Contemp Clin Trials. 2007;28(4):401-8.
7. Grant SC. Informed consent—we can and should do better. JAMA Network Open. 2021;4(4):e2110848.
8. Kass NE, Chaisson L, Taylor HA, et al. Length and complexity of US and international HIV consent forms from federal HIV network trials. J Gen Intern Med. 2011;26(11):1324-8.
9. Berger O, Grønberg BH, Sand K, Kaasa S, Loge JH. The length of consent documents in oncological trials is doubled in twenty years. Ann Oncol. 2009;20(2):379-85.
10. Wen G, Liu X, Huang L, et al. Readability and content assessment of informed consent forms for phase ii-iv clinical trials in China. PLoS One. 2016;11(10):e0164251.
11. Epstein LC, Lasagna L. Obtaining informed consent. Form or substance. Arch Intern Med. 1969;123(6):682-8.
12. Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol. 2007;25(9):e13-4.
13. Nishimura A, Carey J, Erwin PJ, et al. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics. 2013;14:28.
14. Pietrzykowski T, Smilowska K. The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials. 2021;22:57.
15. Tam NT Huy NT, Thoa LTB, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186-98h.
16. Tait AR, Voepel-Lewis T, Nair VN, Narisetty NN, Fagerlin A. Informing the uninformed: optimizing the consent message using a fractional factorial design. JAMA Pediatrics. 2013;167(7):640-6.
17. Perrault EK, Keating DM. Seeking ways to inform the uninformed: improving the Informed consent process in online social science research. J. Empir. Res. Hum. Res. Ethics. 2018;13(1):50-60.
18. Koonrungsesomboon N, Teekachunhatean S, Hanprasertpong N, et al. Improved participants’ understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study. Eur J Clin Pharmacol. 2016;72(4):413-21.
19. Koonrungsesomboon N, Tharavanij T, Phiphatpatthamaamphan K, et al. Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials. Eur J Clin Pharmacol. 2017;73(2):141-9.
20. Koonrungsesomboon N, Traivaree C, Tiyapsane C, Karbwang J. Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial. BMJ Open. 2019;9(11):e029530.
21. MSSS. Éthique de la recherche : Clauses légales. Gouvernement de Québerc; 2021.
22. Lix Score and readability. Lix score.
23. Buccini LD, Caputi P, Iverson D, Jones C. Toward a construct definition of informed consent comprehension. J Empir Res Hum Res Ethics. 2009;4(1):17-23.
24. Addissie A, Abay S, Feleke Y, et al. Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting. BMC Medical Ethics. 2016;17:40.
25. Kon AA, Klug M. Methods and practices of investigators for determining participants’ decisional capacity and comprehension of protocols. J Empir Res Hum Res Ethics. 2006;1(4):61-8.
26. Institut de la statistique du Québec. Niveau de scolarité; 2025.
27. Koonrungsesomboon N, Charoenkwan P, Natesirinilkul R, et al. What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials. BMC Medical Ethics. 2022;23:113.
28. Kadam RA. Informed consent process: A step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107-12.
29. Statistics Canada. Literacy, numeracy - Average scores and distribution of proficiency levels, by labour force status, highest level of education and age group. Table 37-10-0049-01. 22 Jun 2015.
30. National Center for Education Statistics (NCES). Skills of U.S. unemployed, young, and older adults in sharper focus: results from the Program for the International Assessment of Adult Competencies (PIAAC) 2012/2014. In: US Department of Education, editor. Washington (DC): NCES; 2016.
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Copyright (c) 2026 Claudia Lord, Gabrielle Gauthieur, Emma Legault, Irina Mitrea, Patrick Gogognon, Hélène Roy, Denis Lebel, Pascal Bédard, Marie-Élaine Métras
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